Epidemiological Study of Dry Eye Disease in Stavanger: Dr... | NCT04458012

Studies
Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients Treated With Intravitreal Injections

NCT04458012

Sponsor

Helse Stavanger HF

Status

Unknown status

Last Update Posted

Jul 7, 2020Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Dry Eye

Interventions

Oculus Keratograph. Schirmer test. Tear fluid sample.

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2020Actual

Primary Completion Date

Jun 25, 2023Estimated

Completion Date

Jun 2024Estimated

First Submitted Date

Jun 30, 2020

First Submission Date that Met QC Criteria

Jul 2, 2020

First Posted Date

Jul 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2020

Last Update Posted Date

Jul 7, 2020Actual

Name	Class
Tor Paaske Utheim	UNKNOWN
Vegard Asgeir Forsaa	UNKNOWN
Vilde Marie Thomseth	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate prevalence of dry eye disease in Norwegian patients with age-related macular degeneration receiving intravitreal injections, as well as to reveal possible risk factors of DED in this population.

Detailed Description

Questionaires (OSDI, McMonnies) and clinical investigation using the Oculus 5 Keratograph for objective ocular surface evaluation. Tear fluid samples will be collected for later biochemical analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oculus Keratograph. Schirmer test. Tear fluid sample.	Diagnostic Test	Objective measurements of the ocular surface using Oculus 5 keratograph. Slit lamp examination and tear fluid sample using Schirmer strips.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dry eye disease in patients receiving intravitreal injections		2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AMD diagnosis
Treated with intravitreal injection agents

Exclusion Criteria:

Not able to cooperate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with age related macular degeneration receiving intravitreal injections with anti-vegf.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stavanger University Hospital, Department of Ophthalmology		Stavanger		4068	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided